Description

Brexpiprazole Impurity is a high-purity reference standard used in the analytical development and quality control of the active pharmaceutical ingredient (API) Brexpiprazole. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of specific impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams focused on compliance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods.
• Impurity Profiling & Identification: Used in HPLC, UPLC, and LC-MS analyses to identify, characterize, and quantify Brexpiprazole-related impurities during API and finished product development.
• Method Development & Validation: A critical component in developing and validating stability-indicating assay methods as per ICH Q2(R1) and Q3A/B guidelines.
• Quality Control & Batch Release: Employed in routine QA/QC testing to monitor impurity levels and ensure batch-to-batch consistency of Brexpiprazole API.
• Regulatory Submissions: Provides necessary data and reference samples for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and specifications.
• Stability Studies: Used as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).

Basic Information

Product Name	Brexpiprazole Impurity
CAS No.	2059954-32-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Brexpiprazole Related Compound; Brexpiprazole Specified Impurity; 7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1,2,3,4-tetrahydroquinolin-2-one Impurity; UNII-9F8S6A6D1C Impurity; OPC-34712 Impurity; Rexulti Impurity
EINECS	Contact for details

Quality Control

Our Brexpiprazole Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment supports your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.